The present invention relates to dispensing and monitoring adherence to the correct ingestion of prescribed pharmaceutical pills/capsules for a medical patient. The United States healthcare is at jeopardy, with approximately three trillion dollars spent in 2014, and a projected increase by 5.85% by 2025. Although such tremendous spending occurs, the United States straggles behind all of her first world countries, implying that most of the spending is a waste. Out of the many causes behind such an enormous problem, it is noncompliance that is the most wasteful out of all. Occupying a third of healthcare waste, noncompliance is the origin and root of healthcare waste in the United States. Approximately 290 billion dollars were wasted in this sector in 2012, with a continual rise since. Defined as the degree of impassiveness of a patient in adhering to advice given by a prescriber or doctor, medical noncompliance has surpassed all other crises faced in healthcare today.
There are many reasons and consequences behind medical noncompliance. Reasons behind compliance can include correlations between race, gender, age, in addition to experiencing unwanted side effects, financial issues, etc. Its consequences are drastic, leading to avoidable hospitalization, false results in clinical studies, and decreased efficiency for doctors, pharmacists and other medical personnel.
Although there have been some solutions to such a problem, little is done overall to solve it. Even the most effective technologies in the market, pill bottles, are either too expensive, or do not solve the initial problem of noncompliance. With the creation of a patented device, Medicobox™ pill compliance device is able to efficiently and effectively provide immediate compliance to the patient, doctor, pharmacist and other healthcare providers. In addition, it provides a reminder system to limit unintentional compliance such as forgetfulness. This is incredibly beneficial to doctors because not only is noncompliance limited, the Medicobox™ can help doctors decide on the next course of action, such as prescribing another drug.
In 2014, the United States healthcare rose to three trillion dollars, with a projected increase of 5.8% by 2025. The cost per capita of the healthcare system has risen by approximately 3,000 dollars since 2004, and is expected to rise by 4.8% over the coming years. Contrary to intuition, however, the healthcare of the United States strays behind other first-world countries such as Australia, France, Canada, etc. although it spends the most out of these countries.
Similar rankings; as represented in Table 1, have shown how healthcare drags behind in 2010, 2007, 2006 and 2004, along with last-place ranks in efficiency, equity, and cost-related problems in all four years:
These rankings are due to a significant amount of waste, which arises from multiple sources, the first of which is the failure of proper care delivery, in which execution of proper care processes, or methods are not able to be delivered properly to the patient. By implementing solutions towards this problem can alone potentially save approximately 100 billion dollars. Secondly is overtreatment, in which unnecessary and excessive amounts of medication and/or other treatments are administered to the patient. This not only wastes money, but also does not enhance or improve the patient's health regimen. This portion can potentially save approximately 158 billion dollars. Finally, fraud and abuse, which involves scams, and corrupt medical practices. Solving such problems would save approximately 82 billion dollars. In total, approximately 750 billion dollars are wasted by the United States, which could be used more effectively in other fields of the government. Table 2 represents this healthcare expenditures divided into its respective causes.
To create an effective analogy to provide a realization of this cost, the United States spent 757 billion dollars within the span of eight years in the Iraq war. In contrast, 750 billion dollars are simply wasted every year by the health system.
In addition, investment is not contributed to either research or development, resulting in the significant waste today. To take the example of GOOGLE®, one can first analyze the holistic revenue of the company itself—approximately 74.54 billion dollars per year. Out of this, approximately 8 billion is spent on research and development. The research and development portion of the 3 trillion healthcare budget is simply 1 billion dollars, too meager for any major problem to be resolved.
However, the most wasteful but overviewed practice today is noncompliance. Occupying a third of healthcare waste of resources, noncompliance is the origin and root of healthcare waste in the United States. As shown in Table 3, approximately 290 billion dollars were wasted in this sector in 2012, with a continual rise since.
Defined as the degree of impassiveness of a patient in adhering to advice given by a prescriber or doctor, medical noncompliance has surpassed all other crises faced in healthcare today. Medical noncompliance is a very broad issue; therefore, the term medication noncompliance, which is specifically the act of not taking medication as advised by the healthcare provider or simply not taking medication at all is used. Note that both terms medical noncompliance and medication noncompliance will be used interchangeably for the sake of a lack of confusion.
Approximately 25-50% of Americans were noncompliant with their medication as of 2012, and this value increased as the population of adults having at least one prescription increased from 38% between 1988-1994 to 49% between 2007-2010—due to the fact that more adults are administering medication. Because the number of patients with chronic diseases have also increased on average by at least 77% in older adults, one can predict a rise of noncompliance in the near future of healthcare—which would also create an expense of over at least 10 billion dollars. Over the rest of this paper, problems and solutions to the problem of medical noncompliance will be discussed, and how implementation of different solutions such as the Medicobox™ pill compliance device will increase the efficiency and cost-effectiveness of healthcare.
There is a major difference when one considers the terms compliance and adherence in terms of medical definitions. In the rest of this essay, although the terms adherence and compliance will be used interchangeably, clear distinction in connotations must be established. “Compliance”, unlike “adherence”, tends not to be as prevalent in the health industry as much as the word “adherence” does because “compliance” implies an obligation of the patient towards the doctor's advice over the true reality, in which a therapeutic alliance is formed between the doctor and patient, as demonstrated by the term adherence. These terms, however distinctive, will be used interchangeably throughout the paper.
To solve the immense problem of non-adherence, one must look into the current methods of adherence measurement. Adherence is measured as the percentage of the amount of medication the patient has taken over a select period of time. This generality can be specified by including the time and dosage of the administration of medication based on the prescription of the patient specifically. Other methods of measuring adherence is by determining the medication possession ratio(MPR), or determining the proportion of days covered(PDC). MPR is measured by the amount days a certain refill is supposed to persist, over the amount of days the medication is in the possession of the patient(such as the time between the first day and the day the patient comes for a refill).
This is shown below in Table 4.
The second method, PDC, is calculated by the amount of days supplied by the pharmacist over the number of days in the interval(Table 5). When both calculations lead to a percentage higher than 80%, the patient is said to be adherent or compliant.
However, both methods have subtle differences between one another. For example, for patients with 3 regimens to be administered in a day, but administers only one regimen per day would be accounted for in MPR calculations; however, under PDC calculations, the specific patient will not be accounted for until all three pills are taken by the patient. Therefore, PDC is a more accurate measure to track compliance. Both methods, along with questionnaires are used by clinics and doctors to determine adherence for indirect purposes. To measure adherence directly, direct observation of patient is done. In addition, testing of urine or other bodily fluids can be done to determine whether certain medication has been taken. However, this is rarely used as it is very costly, and inefficient for medical personnel.
Already one can view flaws in the method used to measure adherence in healthcare. However indirect measures taken by doctors and nurses are used in the twenty-first century, not only are they accurate, it is not a viable resource for the healthcare industry to use as there are multiple leeways that can be utilized by patients to provide incorrect, falsified, or misleading evidence of adherence. For example, a patient may simply bring back an empty container claiming that he/she has taken the medication; meanwhile, the remaining pills are compiled into another container, to which the pharmacist does not have the knowledge of.
This situation can simply be represented in the following case study: A 53 year-old man was diagnosed with insulin resistance and type 2 diabetes mellitus. To treat this, the doctor advised him to “modify his diet, increase his level of activity as much as possible, and finally was prescribed oral metformin to be taken with meals”. However, after a three month follow-up, the patient's status does not change: his weight is the same, hemoglobin levels do not decrease significantly. The patient admits to not having enough exercise, nor did he try to change his eating habits. However, he asserted that he has been taking his medication as directed. Before prescribing another medication for the patient, the doctor first decides to check whether the patient is actually adhering to the prescription. He instructs the patient to bring in his pill bottle in the next follow-up. Next, the doctor calls the local pharmacy, and finds that the patient did come for a refill in a timely manner. In the next follow up, the patient confessed that he did not take his pills as prescribed by the doctor, his reason being that he was “too tired”, or “forgot to take his medication.” In addition, the patient stated that he has more pills at the medicine cabinet at his house. When using the methods of measuring compliance such as the MPR or PDC method, one can see that the current adherence measurement methods do not apply or are not helpful in this case study. Healthcare personnel such as physicians can potentially be misled when encountering such a scenario.
The problem of non-adherence has led to drastic consequences affecting the patient, the doctor, employer, pharmacist, etc. One consequence of noncompliance is the number of avoidable, unnecessary hospitalizations. A vast contribution to the cost of avoidable healthcare wastes, 213 billion dollars are wasted due to avoidable hospitalization. Avoidable hospitalization due to noncompliance not only decreases the number of patients who can be cured in a certain period of time, but it also causes unnecessary financial pressures on patients, employers and employees. Because of continual visits to the hospital and the average income being approximately 50,000 dollars in 2014, patients can no longer afford the high cost of hospitalizations. This is due to the fact that without insurance, three-day hospitalizations cost approximately 30,000 dollars—more than half of the average income of the average person in the United States. This is not including the cost of medication itself. Hepatitis C pills cost 1000 dollars per pill without insurance—meaning that a four month-period of medication can cost approximately 84,000 dollars—too high for patients to pay for them. Since more patients cannot enter the hospital for care, hospital employers can no longer receive the profits and income that they had before—as antidote, healthcare prices are increased to restore profits for the hospital. As shown in Table 6, approximately 8 million dollars can be saved by hospitals if adherence is increased, not including the great number of potential lives increased adherence can save.
Associations have also been made with increased noncompliance and hospitalization, and mortality rates. In a study of 557 patients suffering from cardiovascular disease, non adherence was associated with doubling of mortality rates and increased hospitalizations. In addition, studies have shown that higher rates of noncompliance of the patient lead to a higher risk of developing a serious disease or side-effect. Studies have also shown noncompliant patients with diseases such hypoglycemia develop and acquire other complications such as acute myocardial infarction once noncompliance has reached a certain degree. Similar results have been displayed in diabetes, in which higher rate of noncompliance can potentially lead to increased levels of glycosylated hemoglobin, blood pressure, and cholesterol levels. This leads to a higher rate of hospitalization of the patient. Statistics show that one-third of all hospitalizations involving adverse reactions are due to non-adherence. 69% of all of the money wasted in healthcare is due to this problem. Finally, non-adherent patients are 17 percent more likely to be hospitalized than adherent patients, and are subjected to a higher medical bill (by approximately 3757 dollars) than one who is adherent. These devastating statistics show us the immediate need to lower non adherence. On the other hand, increased compliance, as shown in Table 7 shows a study in which increased adherence have been linked to decreased hospitalization.
Another consequence of non-adherence is the effect that noncompliance has on clinical outcomes. Non-adherence that occurs during clinical trials are known as artifactual non-adherence. In these trials, adherence is assumed under ideal conditions—in which all medication is taken as prescribed. Such is the case of the Ideal Trial, which is a double-blind experiment where adherence is perfect:
A sample of participants are split into two groups: Group A which will receive the placebo, and Group B, which will receive the experimental drug. Neither the doctor nor the participant know which drug is administered or received. All participants take their pills as assigned and report for refills at the correct time. Data is recorded at the proper time, and a conclusion regarding the difference between the two treatments.
One can definitely infer that in reality, this does not ever happen. Statistics displays that this is most definitely false—both real world situations and experimental(simulated) situations, non-adherence thrives among the population. Non-adherence is not limited to taking medication in regards of the prescription—in clinical trials, participating in multiple trials at once is also considered artifactual due to the fact that certain drugs can conflict outcomes. This leads to misleading evidence, which interferes accurate hypothesis testing and conclusions, with results that may be detrimental to the population. Average adherence rate in trials is only 34-78%. This is in addition to the 30% who dump their medications before study visits. At the same time, deceptive and artifactual evidence can be completely unrelated to the hypothesis being tested-which leads to a waste of money, and a waste of time, as shown in Table 8.
In the following case study, low, or no adherence can cause problems in clinical trials:
A 42 year old male participating in a schizophrenia study was also participating in another study. While explicitly stating that he is not currently participating in another study, he laughed when confronted about the issue, stating “you caught me”. In addition, he admitted to only take the medication when his “head felt clearer”, although he had previously reported a 100% adherence by pill count.
Such a problem can occur with other individuals, which leads to a higher inaccuracy in data selection. Multiple or coupled non-adherence can lead to a higher impact on study power. For example, if approximately 30% of patients are noncompliant and do not give reliable data, then the study's results would be powered to approximately to 85% to 95%, where a true power would result to be 60% to 70%. This is further exemplified in Table 9.
Powering the data of an experiment using noncompliance is definitely detrimental. This is represented in the following case study:
In 2004, the New England Journal of Medicine published the results of a study of the Women's Health Initiative regarding Calcium and Vitamin D in relation to Osteoporosis. The trial was established to provide a supplement given over the counter to reduce the amount of fractures resulting in postmenopausal women. Such a trial involved approximately thirty thousand women, and seven years' worth of data.
Although such an experiment was deemed an achievement, results did not conclude as expected. Conclusions were made, but with multiple sources of error. By the end of the trial, an enormous number of women did not take their pills. Approximately 24% admitted to not take medication, while only 59% were taking 80% of the medication as prescribed. This was measured by a pill recount method, which actually overestimates compliance.
This creates the hypothetical question which dictates whether such trials involving so much noncompliance should be acknowledged as reliable. With an incredible amount of money put on such a project, pressures on scientists, and experimenters can be forced to make conclusions, even though such conclusions can easily be rejected. In addition, trials that may be on the path to producing drugs that may have the potential to eradicate the world of potent diseases may be biased, falsified, or simply inaccurate of the population—leading to potential damage to the entire population, or creating extraneous complications. In addition, another study involving the discontinuation of tamoxifen (trade name NOLVADEX), used to treat breast cancer, concluded that approximately 88 out of the 516 participants decided not to take medication after two years of the study. This was also accompanied with a negative belief towards the medication and a positive status towards discontinuation.
Another consequence of noncompliance is the rise of drug-resistant bacteria. Because patients do not usually take medication as directed, incorrect habits form, which threatens the patient in addition to the population. Common behaviors of taking premature, sporadic or intermittent halts in antibiotic regimens in addition to administering higher doses of medication in the beginning of the treatment regimen leads to resistant bacteria. Because of sporadic or intermittent noncompliance, drug resistant diseases develop. An example of this includes the case of tuberculosis. Because of non-adherence, patients who now contain the “secondary drug resistance” are able to occasionally transmit disease from one patient to another—which creates not only sets a panic to look for a stronger drug to kill the disease, but infects medical personnel and patients as well—creating more sick patients and therefore, increasing hospitalization. In addition, children are more vulnerable due to their compromised immunities. This is represented in the following case study: When a patient using antiretrovirals decided to take medication intermittently instead of everyday due to the fact that he could not afford the copay for the medication, he unknowingly becomes resistant to the medication. With the advent of superbugs, it is especially important to lower noncompliance rates of newly developed drugs, as if resistance of these drugs can lead to a loss of many lives, and endanger the general population as a whole.
The most important and common consequence of medical non adherence is that healthcare professionals lack knowledge or data regarding the adherence of the patient. An analogy is a wall between the patient and the doctor, whereas ideally, the doctor should be able to directly interact with the patient during the treatment regimen instead of using a somewhat qualitative approach to determine patient compliance data. Such a qualitative approach includes doctors depending on the patients to do their part, taking their medication. However, not only has it been shown that the majority of the population does not take their medication as directed, but doctors cannot receive evidence denoting the fact that the patient is taking their medication; simple word of mouth is not enough to determine whether the patient is compliant. This negatively affects doctors, who do not know why the patient is not healing.
Although noncompliance can lead to many consequences such as an effect to hospitalizations and clinical trials as well as antibiotic resistance, the reason behind noncompliance is still debated among researchers. Noncompliance comes in two different types: intentional and unintentional. Intentional noncompliance is the action of deliberately not taking medication at all or as prescribed by a health personnel. This is usually a decision made by the patient while weighing the potential benefits and harms when taking a drug. Side-effects and drug dependency may take a role in such a decision. This is due to three reasons: a lack of knowledge on the potential advantages or disadvantages when taking another medication, when the phenotypic benefits of the treatment is either not visible, or not obvious, and the physiological adaptation needed to sense the need of help or treatment. First of all, patients do not have much of a context as to how the medication will change their daily lifestyle. Clinical records simply show adverse life-threatening reactions, but never display the change in the quality of life for the patient. Because of the faulty appraisal of the medication, negative side-effects become not only an unpleasant surprise to the patient, but also taking medication becomes a burden that the patient is now unwilling to take. For example, if a doctor prescribes a new drug to a patient with a certain illness, he/she will tell the patient that the medication will “cure the illness”, and help the patient in that sense, but will not tell the patient of a possible unpleasant side-effect such as getting headaches; which leads the patient to think negatively of the drug itself. Secondly, benefits of a certain drug is not visible to the patient. In the previous example, the patient may not know that his/her illness is being cured, due to a lack of phenotypic difference by the drug. Instead, the patient phenotypically experiences the side-effect, once again giving a negative envisioning of the drug itself. This is fairly common on drugs which do not have a cure guaranteed for the patient, which would lead to a questioning of the effectiveness of the drug, especially if it produces side effects without a visible benefit Table 10 displays this common, but incorrect perception.
Finally, the prospect of adapting to the fact that a patient is ill is based on the physiology of grief—in which the patient does not comply to the medication due to the fact that he or she may not want to be viewed as or view themselves as ill or sick. In addition, other unrelated issues that may cause grief may cause non-adherence. This is further exemplified in the following case study:
A 54-year old lady had a kidney transplant done when she was 24, and was in a very healthy state, and married a year after her transplant. However, after her husband passed away from a recent heart attack, she fell into a deep state of grief, which led her to temporarily stop taking medication due to her grief.
This shows how depression, although regarding a completely different issue, may affect non adherence.
However, the most important factor causing intentional non-adherence is the fact that medication is much too expensive to the average patient, and the cost of pills are increasing at a very drastic rate. For example, the costs of cancer drugs have been increased from $5000 to $10,000 before 2000, and over $100,000 in 2012. BIOGEN IDEC®'s drug for multiple sclerosis costs $54,900 per patient every year, in addition to Hepatitis C drug costs of $84,000 and Cystic Drug costs of $25
With the average income per person being approximately $51,000, such medication is definitely unaffordable by the general public. This induces medical non-adherence because it changes one's attitude towards the medication, causing him/her to behave adversely. These behaviors include taking pills every other day, taking half a pill every day, or simply taking medication when the illness is strong. Approximately 32% of older patients take less medication than prescribed to avoid high costs. This is done by either sporadically taking medications, especially when pain is received, splitting pills in half to make the prescription last longer, or delaying refills. This halts or delays the healing process, leading to ineffective and inefficient care. In addition, patients also simply discontinue the treatment. This is exemplified in which 15% do not fill out a new prescription. Out of those who do, 50% discontinue using the medication after six months, which creates major losses in the pharmaceutical industries (Table 12).
However, intentional non adherence is definitely not as drastic of a problem as unintentional non-adherence.
Unintentional non-adherence is a more significant and widespread problem in comparison to intentional adherence. Unintentional non-adherence is the result of the patient is willing to adhere to his/her prescriptions but is unable to do so due to obstacles that cannot be controlled by the patient. This includes not being able to recall whether medication has been taken, or not being able to find the medication, etc. Such a problem is very detrimental to pharmaceutical industries as well as other medical industries. In a study involving approximately 24,000 subjects, approximately 62% forgot to take their medication, 37% ran out of medication, and 23% were simply too careless. This is in comparison to only 33% who decided not to take medication intentionally. Unintentional non-adherence involves many different factors, such as age, race, gender; education, etc.
The first factor that will be discussed is age. Age plays a significant role in the elderly population because of the many challenges that they have, such as physical and mental disabilities. Studies show that approximately 40 to 75% of the elderly population do not take medication at the proper time, or the correct amount of medication required due to consequences such as a decreased cognitive and/or physical abilities that are present in higher rates in a younger adult. This is illustrated in Table 13.
In addition, elderly noncompliance accounts for approximately 26% of hospitalizations, and 25% of preventable adverse drug reactions. Finally, elderly noncompliance has caused a waste of billions of dollars in the healthcare industry. However, disputes have occurred based on whether age is a true contributor to noncompliance. For example, in a study based on fecal occult blood screening, compliance was at its peak for ages near 70, but slowly decreased at 80 years of age and 55 years of age.
A second factor that will be discussed is gender. Although there may not seem much of a difference between non adherence rates of men in comparison to women, associations do exist between gender and compliance. For example, women 27% are more likely to be non-adherent than men. Although research has not yet provided a transparent line as to why this tends to happen, explanations have been provided by researchers for this reason. These speculations include the fact that women are perhaps more price-sensitive to paying for out-of-pocket medication, or having a different level of health literacy, which is one's ability to process health information. On the other hand, studies also show that males are related to poor adherence. In one such experiment, males were 15% more non-adherent than females. Although these contrasting studies have yet to be confirmed, gender remains to be a significant factor for noncompliance. Distinctions of proper medication intake in males and females occur by as much as 10%.
A third factor that will be discussed is race. The relationship between race and noncompliance is widely studied among scientists. Caucasians are more likely to have better compliance than Blacks, Hispanics, and other minorities. Although there has not been a consensus behind why this occurs, a plausible explanation may be due to socio-economic barriers and language barriers in these minorities.
Multiple solutions will take place in response to problems stated above. The first solution to the immense problem of medical non-adherence is education. By having the knowledge and understanding the logical reasoning behind taking medication, patients can start increasing their personal rate of adherence. By utilizing education, intentional non-adherence is now decreased due to the fact that the patient will understand that although the cure will not be phenotypic, the medication is benefitting the body. In addition, by educating the public, new financial priorities may be set by the patient after considering the now-learned consequences and dangers of non-compliance. By prioritizing one's finance, the patient is able to pay off medication bills. Behaviors such as taking half a pill, or simply disregarding prescriptions may be nonexistent. Speculations behind the actual benefit of educating the non-adherent populations have been confirmed with numerous studies. For example, in a specific study, diabetes self-education program was tested to examine whether testing would lead to higher adherence rates. The results showed that approximately $415 can be saved by each patient who completes the education program (approximately 12 hours), over the span of three years. Over ten years, it is estimated that there would be a 12% decrease in coronary heart disease events, in addition to a 15% decrease in microvascular disease events.
Education also helps diminish the problem of health illiteracy—a significant problem in healthcare today. Defined as the ability for a patient to obtain, access, and understand health information and services to make appropriate health choices, health literacy has become a significant problem for patients and healthcare providers over the recent years. Approximately only 12% of adults have proficient health literacy. In addition, only 33.3% are able to do menial tasks properly, such as following directions on the prescription. Health illiteracy then becomes a concern because of the fact that the patient may not be able to determine when he/she has to take their medication. In addition, poison warnings or other hazards will not be read or understood, leading to hospitalization or a more extreme event—death. This also leads to shame of a patient, in which the patient is too embarrassed or ashamed to ask for help. In a study, approximately 85% of those who were illiterate did not admit it to their coworkers, and 50% hid their illiteracy from their children. An important factor in health literacy is numeracy. Being the ability for one to understand numbers, this factor is crucial to understanding health information. However, in this field itself, numerous patients struggle to comprehend simple numerical data. Studies show that 16% of highly educated individuals were unable to determine which has a higher risk: 1%, 5%, or 10%.
Education is also associated with the perception in which the patient is in control. In this case, by letting the patient receive the power to make his or her own choices, he/she is then actively participating in the pathway for successful drug compliance. Examples such as allowing the patient to decide when to take medication over having the doctor of pharmacist make decisions for them. Therefore, if the patient prefers taking medication in the morning over the evening, there is a higher probability of adherence in the morning rather than if the pharmacist forces the patient to take medication at night. In addition, medical personnel can also determine the motivation of the patient to cure their ailments, and determine adherence predictions before the patient takes medication. In conclusion, the multifactorial solution of education is able to limit the outbreak of intentional noncompliance in addition to unintentional noncompliance.
The second solution is to promote effective communication between the doctor and the patient. Studies show that poor communication with one's healthcare provider is linked to patient noncompliance. In addition, a study showed that compliance of the patient increased when the doctors are emotionally supportive, and provide empathy towards the patient. It is important for this to happen, as miscommunication can reduce transparency between the doctor and the patient, which usually occurs with multiple medication prescribers. It is shown that patients with multiple physicians and healthcare providers prescribing multiple medications tend to lose confidence in their health regimen. To solve such a problem, patient empowerment is needed. By allowing the patient to actively participate in the health regimen, doctor and patient communication occurs without hesitation by the patient. In addition to empowerment, it is important for patients to share all fallacies in their regimen to their physicians. For example, it is common for patients to admit to noncompliance when prompted, as exemplified in the case study. As displayed on Table 14, this also creates an ill-transparent disparity between the patient and the doctor. As shown in the Table 14 below, patients do not reach the ideal medical practices region, creating a gap between the patient and the doctor.
The third solution is to create an effective reminder system, one that is able to remind the patient to take their medication in addition to maintain compliance of the patient. As established above, unintentional noncompliance is most prevalent due to the fact that patients tend to forget to take their medication. Commonly found in the elderly sector, it is imperative to solve the overarching problem of carelessness and forgetfulness of patients. Reminder systems are effective because they allow the patient to not only take the medication that is required for their health regimen, but also allow the patient to get habituated in taking medication regularly. These reminder systems are only effective, however, if patient contact is at its highest. Therefore, it is important to understand the patient, and accustom the reminder system to how the patient communicates with his/her environment.
To be able to increase communication and prevent unintentional compliance, it is suggested that effective use of technology will be the most cost-effective and efficient to improve the healthcare system. With the coming of the twenty-first century, multiple devices and gadgets can be used in the healthcare system to reduce medical noncompliance. Technology is a very viable instrument that the system can use as it is very inexpensive, but is also very effective in enabling adherence. With the coming of new robots and wireless devices, the idea of using technology is more appealing than ever. However, the technology being implemented in the medical industry today is outdated, and has many flaws, making it less applicable in the 21st century.
One such technology utilized by pharmacists is the use of databases to allow for automated reminders to take medication though automated text messages, emails, and calls. Information regarding the date and time of automated messages would be received by computing metrics based on MPR data—involving the amount of days the patient had access to his or her medication. However, such technology is very inefficient and not beneficial. In a study involving 398 patients, using automated reminders along with monitoring devices did not show any significant benefit to medical adherence. Another study has also showed similar results—in a study with 275 patients, no significant benefit occurred with interventions such as automated and personal phone calls. Such use of technology is not very successful in healthcare today because of multiple factors. First, any benefits in adherence is only intended towards the patient, whereas doctors will not know the health regimen for the patient in terms of adherence. At the same time, pharmacists do not know for sure how many pills the patient took in a select time period. Because of this, neither doctor nor the pharmacists know whether the patient took the medication or not. This leads to the second flaw: the method is not flawless. Instead, it is far from determining actual adherence. Patients can simply decide not to take medication without notifying the doctor or the pharmacist, in addition to ignoring or subscribing to stop automated reminders. When these two effortless procedures are taken, the database is simply useless. Finally, automated reminders are simply not effective in reminding patients to take medication. Reminders can be simply ignored by the patient, and also, the patient can simply turn off reminders from pharmacists (As daily automated reminders can be irritating to some). Therefore, databased and automated reminders and adherence predictions are not effective due to its impracticalities.
Another form of technology involves writing prescriptions, called e-prescriptions, in which prescriptions are written electronically rather than by hand. This makes a major difference because handwritten notes are easily misplaced by patients. In addition, handwritten notes do not provide any verification that the patient came to pick up his or her medication. This behavior usually goes unseen because pharmacists are not aware of the fact that the doctor has prescribed medication to a specific patient. By using electronic prescriptions, pharmacists are able to verify and determine whether certain medication is supposed to be picked up by the specific patient. Also, refills of medication under the awareness of the pharmacist can counter patient forgetfulness to take medication again. Unlike automated phone calls by database-related pharmacies, e-prescribing has led to a benefit in terms of the amount of prescriptions filled (as shown in Table 15).
However, it does not solve the entire problem. There are still many aspects of noncompliance not covered by the idea of c-prescribing. First of all, although there is an increase of prescription pickups, e-prescriptions do not affect the aspect of patients taking medication at home. Secondly, errors occur between pharmacist and doctor communication (due to software problems) which would lead to decreased efficiency. Approximately 1 out of every 10 prescriptions sent result in pharmacist intervention because of a lack of specificity or other complications. More importantly, however, is the cost of such technology. Per prescriber, the cost is approximately 2,500 dollars, too expensive for the average physician. Although electronic prescriptions are helpful to some degree in decreasing noncompliance, its expenses are simply too high for a practical solution.
Although one can see the flaws in the multiple outdated technologies above, the idea of using technology is not diminished. Instead, new technology is implemented to create the items found in a patient's daily life “smart”, meaning that they have enhanced features to accommodate for noncompliance. The most effective of these is the pill-bottle, which is simply the remodeling of the standard pill bottle found in pharmacies into one that is able to do much more than serve simply as a container—a “smart” pill bottle. They are especially beneficial because of the fact that a patient(ideally) is in contact with a medication bottle frequently. Due to this fact, it is easier, and more effective to create the “smart” component in a pill bottle over other medication interactions. An example would be creating a pill bottle that can also remind patients in addition to holding medication.
When discussing pill bottles, we must acknowledge the important factors needed in a pill bottle. By looking at the analysis above, it is determined that the following factors/problems/solutions must be addressed in a pill bottle: communication between doctors and patients, reminder systems in the elderly population, cost-effectiveness in the device, decreased inefficiency of the patient and the doctor, and flawlessness. Before discussing how the Medicobox™ pill compliance device successfully achieves these factors, it is important to see how other pill bottles are designed, and the flaws in their device.
The first device that will be discussed is one that uses a weight sensor to determine compliance (WO 2013127564 A1 of Femtotools AG). In the case of a weight sensor, multiple instantaneous calculations are done to determine compliance. First, the weight of each pill/medication is taken separately. Next, the weight of the entire container is measured. Every time the patient takes the medication, the device will recalculate the mass. The now decreased mass will indicate that the pill has been taken. Although such a scenario is ideal, it is not as practical as envisioned. Any roughness in the environment can now ruin the weight sensor accuracy. In addition, in the case of placing the pill bottle on its side, the reading of the weight will not be accurate at the slightest, and also damage the weight sensor. Finally, the device is relatively in a higher amount of weight, creating an impracticality in the field of portable devices.
Another popular device in the market is the MEDSMART PLUS®Monitored Automatic Medication Pill Dispenser (UPC 837066001289), a device that can send a text message, call, or email to the caregiver if the patient does not take his/her pills within one hour time. This will occur along with sounds and blinking lights to indicate that the patient has not taken pills. This blinking light can be stopped only when the patient actually takes the pills. Unlike the bottle before, this device is able to be transported easily, and can run on batteries. Although such features seem beneficial, it does not fit the criteria established. The dispenser is incredibly expensive, as it costs at least 800 dollars. In the average population, patients are not able to afford such a device. In addition, although the patient's compliance is sent to the doctor, it cannot be organized in a way so it is easier for the doctor to be able to access them. In other words, long term compliance tracking is not achieved by the device in discussion.
Yet another pill case called the MEDSIGNALS pill case. Unlike the other pill bottles, this is able to all the same functions, along with being able to connect to one's landline, and contains a speaker which can speak out instructions to the patient regarding how to take the medication. Similar to other devices before, the device can produce lights and beeping sounds to alert the patient to take the medication. For all of these features, there must be a power source to charge the device.
Another prior art device is disclosed in US 20160324726 A1 of Roberts et al for a Smart Cap For a Medication Container. Robert's '726 uses a weight sensor to detect reduced overall pill capacity weight by virtue of one or more pills being retrieved by the user. Roberts '726 makes use of a bluetooth chip (BLE) connected to a smartphone app. Roberts '726 also uses an RFID Tag which can store information and can release it when a computer is in proximity, and a signal amplifier to amplify the bluetooth and weight sensor signals.
As seen in these top-market pill bottles, the devices are not efficient or cost effective. Nowhere in the market can one see a device that is beneficial also to the doctors and the pharmacists in conjunction to an effective communication between the doctors and the patients. In addition, most of the devices that are available in the market tend to be too expensive for the common patient.